Judy Barkal currently leads Technology and Medical Informatics at M2Gen. She brings deep experience in strategy, innovation and complex business and technology transformation. Judy’s most recent role was Head of Information Strategy and Innovation at Knight Cancer Institute, Oregon Health and Science University. At OHSU, Judy established a cancer informatics strategic roadmap and, as PI, led the creation of a clinical data repository integrated with genomics data to serve multiple cancer researchers and programs. Read her full bio.

Interview with Judy Barkal of M2Gen

Q: Patient healthcare data aggregation and analysis is seen as both the panacea for tremendous breakthroughs in precision medicine and as one of its biggest challenges. Are both true and how so?

A: Certainly, aggregating and analyzing healthcare data is a big challenge, but when we succeed, there are big breakthroughs. M2Gen is currently addressing those challenges head-on, but not alone. We work in collaboration with our ORIEN (Oncology Research Information Exchange Network; ORIENcancer.org) members and pharma partners. Together, we have shown that aggregating and analyzing data does lead to breakthroughs as evidenced by our publications utilizing the Total Cancer Care Protocol and aggregated clinical and molecular data.

Q: What are the biggest hurdles today in getting people to share their health data?

A: Patients tell us that they want to participate in how to share their data. They do not want physicians or institutions to decide for them. Patients want to know who they are sharing their data with, what is being learned, and how can they ask informed questions of their care provider. Once patients decide to share their data, we must be good stewards of that data and ensure their data is secure and shared as promised.

Q: How can they be overcome? What is needed?

A: Asking patients for their consent before using their data is critically important. Providing patients with secure technical means to share their data and being transparent about who is going to see their data – even if deidentified – and for what purposes is also key. M2Gen does nothing until patients consent to the Total Cancer Care protocol. Once consented, patients need communication about how their data is being used for research and how this has led to new knowledge. When we do these things, patients find value in sharing their health data.

Q: What has worked? Can you provide some examples that demonstrate that patients and healthy people can successfully share their data where everyone benefits?

A: M2Gen is the “engine” behind the Oncology Research Information Exchange Network (ORIEN.) There are now 19 ORIEN member sites that represent academic cancer centers and institutions. Patient clinical and genomic data are shared and available for research projects and clinical trials across ORIEN. The data sharing may extend to research institutions outside of ORIEN and pharmaceutical companies who use the data for discovery, clinical trials development, and post-market surveillance. At ORIEN member sites, patients and are consenting to the Total Cancer Care Protocol, providing us with health data, and demonstrating that they are willing to participate in research so that we can all learn more.

Q: We have a long way to go. With clinical trials enrolling at 2-3% today and that number falling. What type and level of shift in culture, laws, collection methods, or other areas is going to be needed to accomplish widespread data sharing?

A: In partnership with the Oncology Research Information Exchange Network (ORIEN), M2Gen manages the administrative and coordination activities of the ORIEN Clinical Trials Network in order to accelerate the availability of clinical trials to patients. We do this by having a central IRB and single Scientific Review Committee (reviews protocols in accordance with Cancer Center Support Grant (CCSG) Guidelines) as well as a central point of contact for sponsors to work with 19 national cancer centers. This approach streamlines operations, helping to decrease R&D costs, run more effective clinical trials and accelerate drug development timelines.

For example, using the Total Cancer Care Protocol as a master trial-screening protocol, M2Gen was able to dramatically accelerate enrollment for an otherwise challenging Biomarker-Driven Clinical Trial in Gastric and Pancreatic Cancers.

M2Gen is also currently collaborating with leading biopharmaceutical companies in the development of “synthetic control arms.” One such example is a Phase 2 CAR-T clinical trial.

Q: How can participants be incentivized to share their health data and other data that researchers need to improve prevention and treatment and develop new therapies and health practices?

A: Total Cancer Care participants share their health data today and want the new knowledge derived from their data to impact other patients and healthcare for the next generation. We frequently hear that patients are seeking a trusted source of information about their disease. Patients want to know what we are learning about patients like them and want information that can help them as they ask questions and have care conversations with their physicians.

Q: Will there always be certain communities or populations that will not participate in research because of history or privacy issues?

A: Participation in research is an individual choice. Sometimes group norms can influence that choice, but the individual patient makes the decision. We begin with a patient’s consent to the Total Cancer Care Protocol before using their data for research because we respect the rights and privacy of every individual. ORIEN has formed a Patient Advisory Council providing a great source of wisdom about communicating with patients from a patient-centric perspective. We feel a sense of stewardship to make the best use of patient data once that patient has graciously consented to participate in Total Cancer Care.

Q: What role will personal technology play in scaling health data sharing and collection?

A: Patients tell us that making it easy and fast to share information is an imperative for engaging them in our research. Advances in personal technology bring new, convenient ways to collect data and new types of data that may not have been readily available before in standard health records. Patients consent to be contacted as part of Total Cancer Care Protocol so we can keep pace with emerging technology and some of the easiest means of collecting data directly from patients.

Q: What do you predict the landscape will look like in 10 years in terms of people sharing their health data? What are the determinants to making your vision a reality?

A: Our vision is that every cancer patient has the opportunity to participate in the Total Cancer Care Protocol. We must be good stewards of the healthcare data by sharing the data in a secure environment that is also accessible to researchers and other stakeholders who may use the data to improve patient outcomes. In addition to ORIEN, there are similar efforts and networks developing to share and learn from patient data. Ultimately, the networks may agree to partner in the development of standardized approaches to collect and organize data, resulting in a “network of networks”. Ideally, patients will reap the benefits of a vast network of stakeholders who have broadened the scope of precision medicine beyond treatment options to meet social, psychological, and financial needs of patients.

Q: Is there anything else you would like to share with the PMWC audience?

A: We, at ORIEN and M2Gen, are excited to be part of accelerating precision medicine. Our belief is that no single group can solve the many challenges with data aggregation and sharing, providing evidence for decision support, drug safety and efficacy and reimbursement. We believe that it will require networks of people willing to share and collaborate for shared value. If you are interested in learning more about M2Gen and ORIEN, please reach out to us. We’d be thrilled to have a conversation and learn more from you about how we might work together to accelerate precision medicine.

Interview with Gabriel Bien-Willner of Palmetto GBA

Q: What does your role entail as the director of the MolDX program at Palmetto GBA?

A: The job directing MolDX is multifaceted; first and foremost the MolDX program is responsible for assessing molecular diagnostic tests on the market and makes coverage and pricing determinations for such tests and technology. This is usually done through local coverage determination policies or technical assessments.

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Interview with Peter Marks of FDA

Q: The CBER’s Regenerative Medicine Advanced Therapy Designation program has been very successful, with about 100 requests for designation in the two years of its existence. Can you please tell us about the program and how it was put together?

A: The Regenerative Medicine Advanced Therapy (RMAT) Designation program came into being as part of the 21st Century Cures Act that was signed into law on December 13, 2016.

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Interview with Calum MacRae of Harvard Medical School

Q: What patient data do we need to better understand the underlying cause of disease and how to prevent it?

A: Medicine at present is highly underdetermined and data poor. To be precise, one must be comprehensive, so medicine (with our consent) will use not only what we currently conceive of as biomedical information, but also data from across our lives.

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Headlines from PMWC 2019 Silicon Valley

A big ‘Thank You’ to all of our presenters and attendees for celebrating 10 years of precision medicine progress with us! PMWC 2019 Silicon Valley was attended by 2000 participants from 35 countries, which included over 400 speakers in 5 parallel tracks!

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Interview with Ken Bloom of Ambry Genetics

Q: Tell us more about your organization/company. What patient population are you serving and which services are you specializing in?

A: Ambry Genetics is a recognized leader in high quality complex genetic testing. We seek to find the genomic cause or contributors to rare diseases, abnormal phenotypes and hereditary disorders.

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Interview with Lee Pierce of Sirius Computer Solutions

Q: What is the state of big data and analytics in healthcare, and how to best use the reams of data available?

A: More than ever, Healthcare organizations are achieving measurable value through use of their data and analytics assets. There is more raw material available than ever to create value. This raw material is the data flowing from internal systems and applications and also from devices and systems external to healthcare organizations.

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Interview with Anita Nelsen of PAREXEL

Q: There are various new, emerging technologies that bring us closer towards a cure for life-threatening disorders such as cancer, HIV, or Huntington’s disease. Prominent examples include the popular gene editing tool CRISPR or new and improved cell and gene therapies. By when can we expect these new technologies being part of routine clinical care?

A: Today’s emerging technologies are making the promise of individualized treatment a reality.

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Interview with Ilan Kirsch of Adaptive Biotechnologies

Q: The Nobel Prize in Medicine was awarded recently to James Allison and Tasuku Honjo for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” What is your first-hand experience the impact that those new drugs had on patients?

A: For decades cancer was viewed as solely a cell-autonomous condition.

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BMS buys Celgene | Lilly buys Loxo Oncology – Does this Signal a Return to Strong Deal-Making Activities in 2019?

Bristol-Myers Squibb’s blockbuster $74B deal to buy Celgene creates an oncology powerhouse amid industrywide excitement about the rapidly evolving science and explosive growth of the sector. The agreement could signal a return to deal-making for the pharmaceutical industry in the $133B global oncology therapeutics market.

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Interview with Gini Deshpande of NuMedii

Q: What need is NuMedii addressing?

A: NuMedii, has been pioneering the use of Big Data, artificial intelligence (AI) and systems biology since 2010 to accelerate the discovery of precision therapies to address high unmet medical needs. Artificial Intelligence approaches are a natural fit to harness Big Data as they provide a framework to ‘train’ computers to recognize patterns and sift through vast amounts of new and existing genomic

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Interview with Minnie Sarwal of UCSF

Q: Genomic medicine is entering more hospitals and bringing with it non-invasive technology that can be used to better target and treat diseases. What are some key milestones that contributed to this trend?

A: Completion of complete sequence data from the human genome project, and the advances in proteomic, microRNA and epigenetic assays added a layer of pathway biology to the understanding of human diseases.

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Interview with Shidong Jia of Predicine

Q: Once sequencing has been validated as a clinical solution via trusted workflows, and coinciding with the technological developments driving costs lower, we can expect accelerated human genome profiling for clinical Dx. How soon, do you think, will we see accelerated growth and what can we expect?

A: We will see accelerated human genome profiling for clinical Dx in 2019 and the coming years as more biomarker-based cancer drugs are gaining approval.

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Interview with Iya Khalil of GNS Healthcare

Q: Artificial intelligence (AI) techniques have sent vast waves across healthcare, even fueling an active discussion of whether AI doctors will eventually replace human physicians in the future. Do you believe that human physicians will be replaced by machines in the foreseeable future? What are your thoughts?

A: I think that there’s a lot of speculation and uncertainty around AI, but I don’t foresee a time when we won’t need physicians.

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Interview with Ilya Michael Rachman of Immix Biopharma Inc.

Q: The Nobel Price in Medicine was awarded recently to James Allison and Tasuku for their work on unleashing the body’s immune system to attack cancer, a breakthrough that has led to an entirely new class of drugs and brought lasting remissions to many patients who had run out of options. The Nobel committee hailed their accomplishments as establishing “an entirely new principle for cancer therapy.” Besides CAR T-cell therapy what do you think next generation immunotherapies will look like to successfully combat cancer?

A: The next generation of immunotherapies will build on the insights discovered by immunologists like James Allison and Tasuku Honjo and extend them to modify the body’s response to tumors.

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Join me to Kick off PMWC Silicon Valley in the Santa Clara Convention Center, Focusing on Every Element of Precision Medicine

My team worked in collaboration with Bill Dalton, Kim Blackwell, Atul Butte / India Hook Barnard, Nancy Davidson and Sharon Terry to create a program that touches every component of precision medicine while bringing together all of its key stakeholders. Leading participating institutions including Stanford Health Care, UCSF, Duke Health, Duke University, John Hopkins University, University of Michigan and more will share their learnings and experiences and their successes and challenges, as they make precision medicine the new standard of care for all.

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Johns Hopkins
University Of Michigan

The Precision Medicine World Conference (PMWC), in its 17th installment, will take place in the Santa Clara Convention Center (Silicon Valley) on January 21-24, 2020. The program will traverse innovative technologies, thriving initiatives, and clinical case studies that enable the translation of precision medicine into direct improvements in health care. Conference attendees will have an opportunity to learn first-hand about the latest developments and advancements in precision medicine and cutting-edge new strategies and solutions that are changing how patients are treated.

See 2019 Agenda highlights:

  • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
    • AI & Data Science Showcase
    • Clinical & Research Tools Showcase
    • Clinical Dx Showcase
    • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
    • Digital Health/Health and Wellness
    • Digital Phenotyping
    • Diversity in Precision Medicine
    • Drug Development (PPPs)
    • Early Days of Life Sequencing
    • Emerging Technologies in PM
    • Emerging Therapeutic Showcase
    • FDA Efforts to Accelerate PM
    • Gene Editing
    • Genomic Profiling Showcase
    • Immunotherapy Sessions & Showcase
    • Implementation into Health Care Delivery
    • Large Scale Bio-data Resources to Support Drug Development (PPPs)
    • Microbial Profiling Showcase
    • Microbiome
    • Neoantigens
    • Next-Gen. Workforce of PM
    • Non-Clinical Services Showcase
    • Pharmacogenomics
    • Point-of Care Dx Platform
    • Precision Public Health
    • Rare Disease Diagnosis
    • Resilience
    • Robust Clinical Decision Support Tools
    • Wellness and Aging Showcase

See 2019 Agenda highlights:

    • Five tracks will showcase sessions on the latest advancements in precision medicine which include, but are not limited to:
      • AI & Data Science Showcase
      • Clinical & Research Tools Showcase
      • Clinical Dx Showcase
      • Creating Clinical Value with Liquid Biopsy ctDNA, etc.
      • Digital Health/Health and Wellness
      • Digital Phenotyping
      • Diversity in Precision Medicine
      • Drug Development (PPPs)
      • Early Days of Life Sequencing
      • Emerging Technologies in PM
      • Emerging Therapeutic Showcase
      • FDA Efforts to Accelerate PM
      • Gene Editing / CRISPR
      • Genomic Profiling Showcase
      • Immunotherapy Sessions & Showcase
      • Implementation into Health Care Delivery
      • Large Scale Bio-data Resources to Support Drug Development (PPPs)
      • Microbial Profiling Showcase
      • Microbiome
      • Neoantigens
      • Next-Gen. Workforce of PM
      • Non-Clinical Services Showcase
      • Pharmacogenomics
      • Point-of Care Dx Platform
      • Precision Public Health
      • Rare Disease Diagnosis
      • Resilience
      • Robust Clinical Decision Support Tools
      • Wellness and Aging Showcase
  • Luminary and Pioneer Awards, honoring individuals who contributed, and continue to contribute, to the field of Precision Medicine
  • 2000+ multidisciplinary attendees, from across the entire spectrum of healthcare, representing different types of companies, technologies, and medical centers with leadership roles in precision medicine
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